In an attempt to alleviate concerns about the safety of itsproducts raised by negative media reports and Food and DrugAdministration re-labelling requests, Collagen Corp. announceda physician indemnification program on Tuesday.
The program indemnifies physicians "against damages andlegal fees arising from lawsuits brought to a jury trialalleging that a patient's polymyositis/dermatomyositis(PM/DM) was caused by collagen injections administered inaccordance with the package insert."
The FDA sent the company a letter on Monday requesting thatcollagen products bear a label warning about a possibleassociation of collagen and PM/DM, two rare autoimmunediseases.
Ann Mathieson, director of product management, said thecompany would enter into indemnification agreements withphysicians who are sued. She said, however, that the companywas not setting aside any funds to account for potentialsettlements under the program.
"We're not expecting an onslaught of lawsuits," Mathieson said."We intend the program as a strong message to physicians andpatients that we stand behind the safety of our product."
The Palo Alto, Calif., company said preliminary informationlinking its products to higher-than-expected incidence of theautoimmune diseases does not prove a causal relationship."Historical information that is available significantly rebuts"these contentions, Frank Delustro, vice president of scientificaffairs, told BioWorld.
The company said it welcomes suggestions that the FDA mightrefer the issue to the Centers for Disease Control or to a panelof scientists for resolution. "The FDA and Collagen are workingtoward the same goal, that patients feel safe with collagenproducts," according to Delustro.
The company's stock (NASDAQ:CGEN) closed at $16.25, up 75cents, on Tuesday.
-- Steve Usdin BioWorld Washington Bureau
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